Ulcerative ColitisPhase 2NCT05372939
Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
A Phase 2 study testing AMT-101 (oral) and Humira (adalimumab) in people with Ulcerative Colitis, run by Applied Molecular Transport at 18 sites in 4 countries.
Trial summary
Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- AMT-101 (oral) and Humira (adalimumab)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 5 Feb 2021to 13 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 to 75 years.
- Moderate to severe UC.
- Eligible for Humira (adalimumab) therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
- Written informed consent must be obtained and documented.
Who cannot join
- Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
- History or current evidence of colonic or abdominal abnormalities.
- Prohibited therapies or procedures before the screening period as specified per protocol.
- A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.
- Pregnant or lactating females.
- Current or recent history of alcohol dependence, illicit drug use, mental or legal incapacitation, or a history of clinically significant psychiatric disorders that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
- Unable to attend study visits or comply with procedures.
- Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Poland10 sites
NZOZ Vitamed
Bydgoszcz, 85-079
Centrum Medyczne LukaMed Joanna Łuka-Wendrowska
Chojnice, 89-600
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Łuka -Wendrowska
Grudziądz, 86-300
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, 44-190
Centrum Innowacyjnych Terapii Sp. z o.o. Oddzial w Piasecznie
Piaseczno, 05-500
Centrum Medyczne Medyk
Rzeszów, 35-326
H.T. Centrum Medyczne - Endoterapia
Tychy, 43-100
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
Warsaw, 03-580
Bodyclinic sp z o.o. Sp. Kom.
Warsaw, 03-712
Centrum Medyczne Melita Medical
Wroclaw, 50-449
Ukraine6 sites
Medical Center of Limited Liability Company "Harmoniya Krasy"
Kyiv, 01135
Medical Center "OK!Clinic+" of International Institute of Clinical Research LLC, Gastroenterology and Hepatology unit of Hospital department
Kyiv, 02091
Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Hospital", Therapeutic Department
Kyiv, 04078
Municipal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov of Vinnytsia Regional Council", Regional Specialized Clinical gastroenterological Center
Vinnytsia, 21028
Municipal non-profit enterprise "Vinnytsya City Clinical Hospital No1", Gastroenterology Department
Vinnytsia, 21029
Medical Center of Limited Liability Company "Medibor", Department of Daycare, Day Surgery with Intensive Care Ward
Zhytomyr, 10003
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects With Moderate to Severe Ulcerative Colitis
Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.
Read the detailed description
This is a Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study to evaluate the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- AMT-101 (oral), Placebo (oral), Humira (adalimumab)
- Keywords
- Inflammatory Bowel Diseases
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-101 (oral)Drug
AMT 101 is orally administered biological therapeutic taken once daily
Placebo (oral)Other
Orally administered placebo comparator taken once daily
Humira (adalimumab)Combination product
Humira comparator is administered subcutaneously, on Humira frequency schedule.
| Study group | Role | What they receive |
|---|---|---|
| AMT-101 and Humira (adalimumab) | Active comparator | AMT-101 Tablet Receives: Drug: AMT-101 (oral); Combination Product: Humira (adalimumab) |
| Placebo and Humira (adalimumab) | Placebo comparator | Placebo Tablet Receives: Other: Placebo (oral); Combination Product: Humira (adalimumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity
Measured: 8 weeks
Secondary outcomes (7)
Mean change in Robarts Histopathology Index (RHI) from baseline
Measured: 8 weeks
Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline
Measured: 8 weeks
Mean change in fecal calprotectin from baseline
Measured: 8 weeks
Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline
Measured: 8 weeks
Proportion of subjects who achieve a significant reduction in RHI
Measured: 8 weeks
Clinical remission rate
Measured: 8 weeks
Clinical response rate
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start5 Feb 2021
- Primary completion1 Jun 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Molecular Transport
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372939
- Sponsor's protocol ID
- AMT-101-203
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05372939
- Acronym / sponsor ID
- AMT-101-203
- Conditions
- Ulcerative Colitis
- Keywords
- Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Applied Molecular TransportIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.
Detailed description
This is a Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study to evaluate the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMT-101 and Humira (adalimumab) | Active comparator | Drug: AMT-101 (oral), Combination Product: Humira (adalimumab)AMT-101 Tablet |
| Placebo and Humira (adalimumab) | Placebo comparator | Other: Placebo (oral), Combination Product: Humira (adalimumab)Placebo Tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged 18 to 75 years.
- Moderate to severe UC.
- Eligible for Humira (adalimumab) therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
- Written informed consent must be obtained and documented.
Key exclusion criteria (8 listed)
- Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
- History or current evidence of colonic or abdominal abnormalities.
- Prohibited therapies or procedures before the screening period as specified per protocol.
- A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.
- Pregnant or lactating females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMT-101 (oral)AMT 101 is orally administered biological therapeutic taken once daily | Drug | AMT-101 and Humira (adalimumab) |
| Placebo (oral)Orally administered placebo comparator taken once daily | Other | Placebo and Humira (adalimumab) |
| Humira (adalimumab)Humira comparator is administered subcutaneously, on Humira frequency schedule. | Combination product | AMT-101 and Humira (adalimumab), Placebo and Humira (adalimumab) |
Primary outcome
Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
Time frame: 8 weeks
To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity
7 secondary outcomes
Mean change in Robarts Histopathology Index (RHI) from baseline
Time frame: 8 weeks
Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline
Time frame: 8 weeks
Mean change in fecal calprotectin from baseline
Time frame: 8 weeks
Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline
Time frame: 8 weeks
Proportion of subjects who achieve a significant reduction in RHI
Time frame: 8 weeks
Clinical remission rate
Time frame: 8 weeks
Clinical response rate
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMT-101 (oral) and Humira (adalimumab) in people with Ulcerative Colitis, run by Applied Molecular Transport at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Poland, Ukraine, Georgia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.